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Prospective incidence epidemiology study protocol: conducting active surveillance to assess the burden of Lyme disease (BOLD) in primary care practices in endemic areas of six European countries

Por: Begier · E. · Pilz · A. · Loew-Baselli · A. · Harper · L. R. · Stark · J. H. · Bowdery · M. · Halsby · K. · Dzingina · M. · Bezay · N. · Allen · K. E. · Parslow · B. · Gessner · B. D.
Introduction

Lyme disease (LD) is the most frequent tick-borne disease in the moderate climates of Europe. This study will inform the phase III efficacy study for Pfizer and Valneva’s investigational Lyme disease vaccine, VLA15. VLA15 phase III will be conducted in the USA and Europe due to the vaccine’s serotype coverage and public health burden of LD. In Europe, the existence and location of sites that have access to populations with high LD annual incidence is uncertain. This active, prospective surveillance study assesses annual LD incidence at general practice (GP)/primary care sites, allowing for phase III site vetting and better characterisation of LD burden in selected regions for study size calculations.

Methods and analysis

This burden of Lyme disease (BOLD) study will assess LD incidence overall and by site at 15 GP/primary care practices in endemic areas of 6 European countries from Spring 2021 to December 2022 and will be summarised with counts (n), percentages (%) and associated 95% CIs. Suspected LD cases identified from site’s practice panels are documented on screening logs, where clinical LD manifestations, diagnoses and standard of care diagnostic results are recorded. In the initial 12-month enrolment phase, suspected LD cases are offered enrolment. Participants undergo interview and clinical assessments to establish medical history, final clinical diagnosis, clinical manifestations and quality of life impact. Study-specific procedures include LD serology, skin punch biopsies and Lyme manifestation photographs. For every enrolled participant diagnosed with LD, 6–10 age-matched controls are randomly selected and offered enrolment for an embedded LD risk factor analysis. Persistent symptoms or post-treatment LD will be assessed at follow-up visits up to 2 years after initial diagnosis, while patients remain symptomatic.

Ethics and dissemination

This study has been approved by all sites’ local ethics committees. The results will be presented at conferences and published in peer-reviewed journals.

Six month incidence of major adverse cardiovascular events among adults with HIV in northern Tanzania: a prospective observational study

Por: Stark · K. · O'Leary · P. R. E. · Sakita · F. M. · Ford · J. S. · Mmbaga · B. T. · Blass · B. · Gedion · K. · Coaxum · L. A. · Rutta · A. · Galson · S. W. · Rugakingira · A. · Manavalan · P. · Bloomfield · G. S. · Hertz · J. T.
Objectives

We aimed to prospectively describe incident cardiovascular events among people living with HIV (PLWH) in northern Tanzania. Secondary aims of this study were to understand non-communicable disease care-seeking behaviour and patient preferences for cardiovascular care and education.

Design

A prospective observational study.

Setting

This study was conducted at the Majengo HIV Care and Treatment Clinic, an outpatient government-funded clinic in Moshi, Tanzania

Participants

Adult patients presenting to an HIV clinic for routine care in northern Tanzania were enrolled from 1 September 2020 to 1 March 2021.

Interventions

At enrolment, participants completed a survey and a resting 12-lead ECG was obtained. At 6 month follow-up, a repeat survey regarding interim health events and repeat ECG was obtained.

Primary and secondary outcome measures

Interim major adverse cardiovascular events (MACE) were defined by: self-reported interim stroke, self-reported hospitalisation for heart failure, self-reported interim myocardial infarction, interim myocardial infarction by ECG criteria (new pathologic Q waves in two contiguous leads) or death due to cardiovascular disease (CVD).

Results

Of 500 enrolled participants, 477 (95.4%) completed 6 month follow-up and 3 (0.6%) died. Over the 6 month follow-up period, 11 MACE occurred (3 strokes, 6 myocardial infarctions, 1 heart failure hospitalisation and 1 cardiovascular death), resulting in an incidence rate of 4.58 MACE per 100 person-years. Of participants completing 6 month follow-up, 31 (6.5%) reported a new non-communicable disease diagnosis, including 23 (4.8%) with a new hypertension diagnosis.

Conclusions

The incidence of MACE among PLWH in Tanzania is high. These findings are an important preliminary step in understanding the landscape of CVD among PLWH in Tanzania and highlight the need for interventions to reduce cardiovascular risk in this population.

Software‐based interventions for low back pain management: A systematic review and meta‐analysis

Abstract

Introduction

Using software for self-management interventions can improve health outcomes for individuals with low back pain, but there is a dearth of research to confirm its effectiveness. Additionally, no known research has evaluated the effective elements of software-based interventions for low back pain self-management components. This study aimed to synthesize the effectiveness of software-based interventions to promote self-management health outcomes among individuals with low back pain.

Design

A systematic review and meta-analysis was conducted.

Methods

Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Statement, relevant studies up to July 2022 were searched via four electronic databases: PubMed, Embase, Cumulative Index to Nursing and Allied Health Literature, and Web of Science.

Results

4908 adults with low back pain who participated in 23 studies were included. Software-based interventions were effective in reducing fear avoidance (mean difference [MD] = −0.95, 95% CI: −1.45 to −0.44), pain catastrophizing (MD = −1.31, 95% CI: −1.84 to −0.78), disability (MD = −8.21, 95% CI: −13.02 to −3.39), and pain intensity (MD = −0.86, 95% CI: −1.17 to −0.55). Specifically, interventions that included an exercise component were more effective in reducing pain and disability. Additionally, cognitive behavioral therapy (CBT) intervention significantly reduced fear avoidance and pain catastrophizing but had no noticeable impact on disability and pain compared to standard treatment. The certainty of the evidence in this review varied from very low to high across outcomes. The heterogeneity of the study results was significant, suggesting that future studies in this area could optimize the design, time points, measures, and outcomes to strengthen the evidence.

Conclusions

Low back pain self-management interventions delivered through software-based programs effectively reduce pain intensity, disability, fear avoidance, and pain catastrophizing.

Clinical Relevance

Low back pain is among the most common reasons for seeking healthcare visits. Combining exercise and counseling through soft-based programs may effectively address this issue and its associated suffering and disability.

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